Seattle's global-health community may get help from new federal law

Seattle's global-health community is anticipating with excitement a new, little-known federal law that could generate big money for nonprofits working on tropical diseases.

The law passed by Congress and signed by President Bush last fall creates a lucrative incentive designed to spur new treatments for diseases such as malaria and African sleeping sickness that plague millions in the developing world.

The new law offers companies that successfully develop such treatments a special voucher for another, speeded-up review by the Food and Drug Administration.

Here's the kicker: The voucher can be sold to another drug company to speed up review of any product in its own pipeline, a big potential windfall. Three professors at Duke University estimated that such vouchers could be worth more than $300 million apiece to Big Pharma.

That scenario has piqued the interest of Seattle's active global-health sector, including the Bill & Melinda Gates Foundation and local nonprofits such as PATH, the Seattle Biomedical Research Institute and the Infectious Disease Research Institute.

"This program presents a significant opportunity," said Curt Malloy, president of Seattle's Infectious Disease Research Institute, which is developing vaccines for such tropical diseases as leishmaniasis, tuberculosis and leprosy.

"Someday, if we got this money, we could put it toward creating a sustainable institute," Malloy said.

Many of the diseases named in the new law are classified by the World Health Organization as "neglected tropical diseases," infectious diseases that spread in parts of the world with hot, humid climates and poor sanitary conditions. Such diseases are often parasitic and spread by mosquitoes and flies.

Largely eliminated from industrialized countries, these diseases continue to take a heavy toll in parts of Africa, Latin America and Asia. WHO estimates that 1 billion people, about a sixth of the world's population, are infected with one or more of such tropical diseases.

Large pharmaceutical companies have expended relatively few resources on these diseases because they affect poor populations and promise limited financial return. The new law on priority review vouchers seeks to create an incentive for Big Pharma to invest in tropical-disease research.

Local nonprofits that have worked for years on such tropical diseases - and often struggle to find private company partners to fund their research - have high hopes that the vouchers will prove a powerful draw to Big Pharma.

A nonprofit organization that receives FDA approval for a tropical-disease vaccine could sell the resulting priority review voucher to a pharmaceutical firm. Or a nonprofit could secure research funding from a pharma firm, with the understanding that any resulting priority review voucher would go to the pharma partner.

"It adds a tool to our tool kit in terms of being able to attract funding and drive these ideas through development," said Randal Hassler, vice president for operations and finance at SBRI.

Hassler, a former executive at biotechnology giant Amgen Inc., said the voucher system could change the equation for Big Pharma when it comes to neglected diseases.

"For them, the question is, 'What's the potential commercial marketplace for these, what's in it for us?'" Hassler said. The priority review voucher program "provides a way for companies like those and others to become excited about neglected disease investments."

The priority review voucher concept originated in a 2006 paper by three Duke University business professors, Henry Grabowski, Jeffrey Moe and David Ridley. Their proposal caught the attention of Sens. Sam Brownback, R-Kansas, and Sherrod Brown, D-Ohio, who used it to craft the voucher legislation.

The vouchers could be worth a lot of money to Big Pharma. The FDA sets a target of 10 months for reviewing new products and deciding whether to approve them. A priority review cuts that period to six months.

The Duke business professors calculated that for top-selling drugs with $3 billion in sales, the priority review vouchers could mean $322 million in additional value by getting the drug to market sooner.

An FDA spokesman said the agency is developing guidelines for the voucher program and declined to give a timeline for implementation. The concept of priority review itself is not new to the FDA; the agency gives priority to drug candidates that are seen as addressing an unmet medical need.

The $38 billion Gates Foundation, which funds a variety of global health initiatives, is also interested in the voucher program. Microsoft co-founder Bill Gates highlighted the new law in a January speech to the World Economic Forum in Davos, Switzerland.

"Under a law signed by President Bush last year, any drug company that develops a new treatment for a neglected disease like malaria or TB can get priority review from the Food and Drug Administration for another product they've made," Gates said. "If you develop a new drug for malaria, your profitable cholesterol-lowering drug could go on the market a year earlier. This priority review could be worth hundreds of millions of dollars."

The Gates Foundation funds a group called BIO Ventures for Global Health, which seeks to promote biotech investment in neglected disease research. The group has been drawing attention to the priority review vouchers at industry meetings across the country.

David Ridley, one of the authors of the Duke University paper that sparked the voucher legislation, said his two co-authors have talked with Tadataka Yamada, executive director of the Gates Foundation's global health program. A Gates Foundation spokeswoman said no one from the foundation was available for comment.

Chris Elias, CEO of Seattle-based PATH, cautioned that the "devil is in the details" in how the FDA chooses to interpret the voucher legislation. But like other nonprofit leaders, he expressed optimism that the program could be a game-changer in neglected disease research.

"If industry perceives this as a way to improve time to market," Elias said, "this could be a very powerful incentive."